April 2018 Product Focus – Virology (plus New Products)

March 22, 2018
Viral load assay

The Aptima HBV Quant assay is the latest release in a series of viral load assays from Hologic. This FDA-approved assay features a dual-target design, which helps laboratorians deliver accurate results in the face of mutations to guide treatment management. The Aptima HBV Quant assay continues the robust performance demonstrated by the Aptima Virology portfolio with the Aptima HIV Quant and Aptima HCV Quant Dx assays. Run on the fully automated Panther system, this newest assay and collective portfolio ensures delivery of reliable viral load quantitation in the clinical management of patients. Hologic

Transport systems with swabs

Puritan’s UniTranz-RT Universal Transport Systems with PurFlock Ultra flock swabs can be used to conclusively collect and test viruses, chlamydia, mycoplasma, and ureaplasma specimens. They are safe, effective, and easy-to-use. Available in 1mL or 3mL fill configurations, with or without swabs. UniTranz-RT is fully compatible with automation systems, EIA, PCR, DFA, and molecular assays. It has a shelf life of 18 months at room temperature (25°C maximum). Made in the USA. Puritan

Respiratory multiplex proficiency test

The Respiratory Multiplex Proficiency Testing product consists of five samples which are shipped three times per year. The samples are designed for multiplex molecular detection of common respiratory pathogens with similar symptoms. Molecular testing provides laboratories quicker turnaround time and reliable results targeting multiple respiratory pathogens at the same time. WSLH PT offers proficiency testing compatible with laboratory developed PCR tests or respiratory multiplex manufacturer assays. Analytes include Adenovirus, Bordetella, Chlamydophila pneumoniae, Coronavirus, Human metapneumovirus, Influenza, Mycoplasma pneumoniae, Parainfluenza, RSV, and Rhinovirus/Enterovirus. WSLH PT

Immunofluorescence antibody assay

The HELIOS System provides all-in-one IFA HEp-2 slide processing and reading on one platform. The HELIOS combines reliable hardware, intuitive software, and quality reagents for the autoimmune testing workspace, and it can process up to 190 samples and 20 slides on one run. The system provides full sample traceability to reduce the risk of transcription errors. The 3-probe pipetting system quickly prepares the slides for automated image capture and result pre-classification. The HELIOS is FDA cleared to identify seven HEp-2 patterns and one Crithidia luciliae pattern, and includes an on-board IFA library. Grifols


Single-sample micro-osmometer

Advanced Instruments’ newest freezing point osmometer, Osmo1, is suited for clinical laboratories that prefer to directly draw and test small sample volumes. Osmo1 uses a small 20 μL sample size and can measure the osmolality of body fluids—including whole blood, serum, plasma, urine, feces, sweat, and tissue homogenate.

Samples are analyzed one at a time, and the process is facilitated via the operating cradle that allows the test to be run directly from the Ease-Eject Sampler, eliminating any loss of sample.

Osmo1 uses the freezing point depression method to deliver results in just 90 seconds. The Micro-Sample Test Kit now includes the sampler tips, chamber cleaners, and replacement plunger wire conveniently packaged together.

The instrument redesign also includes an interactive touchscreen, an on-board printer, and a 2-D barcode scanner to provide positive sample identification to reduce transcription errors. Data management and transfer can be handled via the on-board printer or by exporting the data using the Ethernet connection or multiple USB ports.
Advanced Instruments

Procalcitonin linearity and calibration verification kit

LGC Maine Standards’ VALIDATE Procalcitonin linearity and calibration verification kit is used for Roche cobas analyzers. The kit, in a human-serum matrix, evaluates procalcitonin (PCT). Each VALIDATE Procalcitonin kit, liquid and ready-to-use and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Laboratorians can dispense the solution from each dropper bottle directly into five sample cups, and run in replicates.

VALIDATE Procalcitonin allows clinical laboratories to complete their required procalcitonin linearity and calibration verification and maximize the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements—such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR)—for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI, and ISO 15189.

LGC Maine Standards manufactures VALIDATE linearity and calibration verification kits for more than 115 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, and Whole Blood Glucose.

LGC Maine Standards MSDRx data reduction software is available at no charge for real-time data analysis, or a laboratory can send its data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days. Peer group comparison is also available upon request.  LGC Maine Standards

Tri-level control for fetomaternal hemorrhage testing

Sure Tech Diagnostics FETALtrol is a tri-level control intended for laboratories having experience in test methods for fetomaternal hemorrhage. FETALtrol can be used to control both flow cytometry assays and manual stains (KB) for the detection of RBCs containing HbF or Rho (D antigen). FETALtrol has 105-day closed vial stability with an open vial stability of 25 thermal cycles, provided they are handled properly. Available in two sizes. Each kit contains three levels of controls. These whole blood controls are stored refrigerated. They are manufactured quarterly in January, April, July, and October. FETALtrol